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Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database (09-SQOL)

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ClinicalTrials.gov Identifier: NCT01353677
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Condition or disease
Hematopoietic Stem Cell Transplantation

Detailed Description:
QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Study Design
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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
Actual Study Start Date : July 2011
Actual Primary Completion Date : October 30, 2014
Actual Study Completion Date : October 30, 2014
Groups and Cohorts
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Group/Cohort
HSCT recipients
  1. Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
  2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
  3. Patient must have a valid mailing address within the United States to receive QOL surveys.
  4. Ability to speak and read English.
  5. Patients with access to a telephone.


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric and adult allogeneic HCT recipients
Criteria

Inclusion Criteria:

  1. Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
  2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
  3. Patient must have a valid mailing address within the United States to receive QOL surveys.
  4. Ability to speak and read English.
  5. Patients with access to a telephone.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353677


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Medical College of Wisconsin
Investigators
Principal Investigator: Douglas Rizzo, MD, MS CIBMTR/ Medical College of Wisconsin
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01353677     History of Changes
Other Study ID Numbers: 09-SQOL
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Center for International Blood and Marrow Transplant Research:
Hematopoietic stem cell transplantation
QOL